BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MODULAR HEAD -6MM

    MDR report key: 2991514 · Received March 6, 2013

    Report

    Report Number
    0001825034-2013-00477
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    December 17, 2012
    Report Date
    July 12, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00473 / 00477).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 5 OF 8 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00473 / -00477 AND 1825034-2014-06410, -06412, AND -06421).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, A LEFT HIP REVISION PROCEDURE WAS ATTEMPTED ON (B)(6) 2012 DUE TO ELEVATED METAL IONS; HOWEVER, THE SURGEON WAS UNABLE TO SEPARATE AND REMOVE THE COMPONENTS AND THE PATIENT WAS CLOSED. THE LEFT HIP COMPONENTS WERE SUCCESSFULLY REVISED ON (B)(6) 2012 AND REPLACED WITH A CEMENT SPACER AS THE PATIENT HAD DEVELOPED AN INFECTION. THE PATIENT UNDERWENT ANOTHER HIP ARTHROPLASTY PROCEDURE TO IMPLANT NEW LEFT HIP COMPONENTS AND REMOVE CEMENT SPACER ON (B)(6) 2012. A SUBSEQUENT REVISION TO EXCHANGE THE MODULAR HEAD WAS PERFORMED ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, A LEFT HIP REVISION PROCEDURE WAS ATTEMPTED ON (B)(6) 2012 DUE TO ELEVATED METAL IONS; HOWEVER, THE SURGEON WAS UNABLE TO SEPARATE AND REMOVE THE COMPONENTS AND THE PATIENT WAS CLOSED. THE LEFT HIP COMPONENTS WERE SUCCESSFULLY REVISED ON (B)(6) 2012 AND REPLACED WITH A CEMENT SPACER AS THE PATIENT HAD DEVELOPED AN INFECTION. THE PATIENT UNDERWENT ANOTHER HIP ARTHROPLASTY PROCEDURE TO IMPLANT NEW LEFT HIP COMPONENTS AND REMOVE CEMENT SPACER ON (B)(6) 2012. A SUBSEQUENT REVISION TO EXCHANGE THE MODULAR HEAD WAS PERFORMED ON (B)(6) 2012. IN ADDITION, THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95180 36MM COCR MODULAR HEAD -6MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 035070

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R